Detailed Information

Field Name

Field Value

Field Description

NDC Code

67225-0007-1

The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.

Package Description

1 TUBE IN 1 PACKAGE (67225-0007-1) > 120 G IN 1 TUBE

A description of the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. For example: 4 BOTTLES in 1 CARTON/100 TABLETS in 1 BOTTLE.

Proprietary Name

2080 K ORIGINAL

Also known as the trade name. It is the name of the product chosen by the labeler.

Non Proprietary Name

SODIUM FLUORIDE

Sometimes called the generic name, this is usually the active ingredient(s) of the product.

Substance Name

SODIUM FLUORIDE

This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

Dosage Form Name

PASTE

The translation of the DosageForm Code submitted by the firm. The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.

Route Name

DENTAL

The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Status

ACTUAL

Status

Last Update

2017-05-02

The date that a record was last updated or changed.

Labeler Name

AEKYUNG INDUSTRIAL CO., LTD.

Name of Company corresponding to the labeler code segment of the ProductNDC.

Strength Number

.12

These are the strength values (to be used with units below) of each active ingredient, listed in the same order as the SubstanceName field above.

Strength Unit

G/120G

These are the units to be used with the strength values above, listed in the same order as the SubstanceName and SubstanceNumber.

11 Digit NDC Code

67225-0007-01

It should be noted that many NDCs are displayed on drug packaging in a 10-digit format. Proper billing of an NDC requires an 11-digit number in a 5-4-2 format. Converting NDCs from a 10-digit to 11-digit format requires a strategically placed zero, dependent upon the 10-digit format.

Product NDC

67225-0007

The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.

Product Type Name

HUMAN OTC DRUG

Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Application Number

PART355

This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category Name

OTC MONOGRAPH FINAL

Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date

20160707

This is the date that the labeler indicates was the start of its marketing of the drug product.